On 14 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved Reliance Life Sciences’ Phase I/III clinical trial for its biosimilar nivolumab (R-TPR-067 or RLS-Nivolumab).
The trial is intended to establish comparability in efficacy, safety, pharmacokinetics, and immunogenicity between R-TPR-067 and the reference product, BMS’ Opdivo® (sold as Opdyta® in India), administered intravenously in patients previously treated for locally advanced or metastatic non-small cell lung cancer.
This puts Reliance ahead of Enzene in their respective efforts to have a nivolumab biosimilar approved in India, as the SEC requested Enzene to revise its Phase III trial protocol. However, both companies lag behind Zydus, which had its nivolumab biosimilar approved in India in July 2024, but which has since faced injunction proceedings before the Delhi High Court.
Amgen, Sandoz and Xbrane/Intas also have nivolumab biosimilars in development.